1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 801 - LABELING
  6. Subpart D - Exemptions From Adequate Directions for Use
  7. 21 CFR § 801.116
21 CFR § 801.116
Medical devices having commonly known directions
June 25, 2020
CFR

A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.

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§ 801.109 Prescription devices
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§ 801.119 In vitro diagnostic products

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